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Type 1 Diabetes clinical trials

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NCT ID: NCT05626725 Recruiting - Type 1 Diabetes Clinical Trials

Safety and Effectiveness of Automated Insulin Delivery (AID) Systems in Physically Active Adults With Type 1 Diabetes

AIDE-1
Start date: December 1, 2022
Phase:
Study type: Observational

Despite recent medical and technological advances, optimal glycemic control (time in range; TIR) and prevention of hypoglycemia remain significant challenges for people living with type 1 diabetes (T1DM). Automated insulin delivery systems (AIDs) combine an insulin pump coupled via an algorithm with a continuous glucose monitor (CGM), allowing constant adjustment of insulin doses according to blood glucose levels. Despite the significant improvement in blood glucose parameters and quality of life with these systems, they are not available to everyone and more and more people with diabetes are resorting to home-made or do-it-yourself (DIY) systems to access this technology. DIY systems are not approved or regulated by Health Canada, despite the growing interest. There have been no studies looking at this type of system in active people living with DbT1, including the risk of exercise-induced hypoglycemia. The primary objective of this study is to evaluate the safety and efficacy of IDA systems in physically active individuals living with type 1 diabetes.This is a real-life observational study in people with commercial IDA (control group) and IDA-DIY. This study includes only one inclusion visit (which may be virtual) and the observation period is 6 weeks. Participants will be required to wear their own artificial pancreas system and give us access to blood glucose and insulin data at the end of the study. They will be required to wear a watch to record physical activity (FitBit). We will ask them to complete information about their diet at least twice a week for a whole day (Keenoa application). Finally, participants will be asked to complete a physical activity diary to complete data (carbohydrates in prevention of activity, insulin suspension, hypoglycemia during or after exercise, etc.).

NCT ID: NCT05626712 Recruiting - Type 1 Diabetes Clinical Trials

Safety and Efficacy of CELZ-201 in Patients With Recent Onset Type 1 Diabetes

CREATE-1
Start date: April 7, 2023
Phase: Phase 1/Phase 2
Study type: Interventional

The brief purpose of this research study is to learn about the safety and efficacy of intra-arterial administration of CELZ-201 in patients with newly diagnosed Type 1 Diabetes Mellitus (T1D).

NCT ID: NCT05622123 Recruiting - Type 1 Diabetes Clinical Trials

BetaFIT Study: Beta Cell Imaging After Faecal mIcrobiota Transplantation

BetaFIT
Start date: February 23, 2023
Phase: Phase 2
Study type: Interventional

The main goal is to investigate whether beta cell mass is correlated to beta cell function after autologous faecal microbial transplantation (FMT) in patients with newly diagnosed type 1 diabetes

NCT ID: NCT05620927 Recruiting - Type 1 Diabetes Clinical Trials

Hypoglycemia Awareness Study in Diabetes Type 1

HAD-1
Start date: November 24, 2022
Phase:
Study type: Observational

The goal of this observational study is to assess clinical factors associated with the occurrence of impaired hypoglycemia awareness in adult patients with type 1 diabetes The main questions it aims to answer are: 1. Determination of the prevalence of impaired hypoglycemia awareness (IAH) in adult patients with type 1 diabetes in the Polish population. 2. Assessment of the clinical usefulness of commonly used standardized scales for the assessment of IAH. 3. Determination of the clinical factors associated with the occurrence of impaired hypoglycemia awareness in adult patients with type 1 diabetes. 4. Determination of the relationship between the occurrence of IAH and the diagnosis of cardiac autonomic neuropathy. 5. Determination of the relationship between impaired hypoglycemia awareness in adult patients with type 1 diabetes and the occurrence of cognitive impairment. Participants will: - fill the standard questionnaires regarding hypoglycemia awareness: Gold, Clarck, HypoA-Q. - have late complications of diabetes checked - have procedure of cardiac autonomic neuropathy assessment - have standard laboratory evaluation during hospitalization

NCT ID: NCT05619198 Recruiting - Type 1 Diabetes Clinical Trials

The Effects of Different Exercise Modalities in Adolescents With Type 1 Diabetes Using AID Systems

MODE2022
Start date: December 19, 2022
Phase: N/A
Study type: Interventional

Objective: The overall objective of this study is to assess the efficacy of the current recommended guidelines for physical activity (PA) in response to acute moderate intensity continous exercise (MICE) and high intensity interval exercise (HIIE) among adolescents with type 1 diabetes (T1D) using automated insulin delivery (AID) systems (MiniMed 780G and Tandem Control-IQ). Methods: This study will be a two-period, cross-over, clinical trial with between and within cohort comparisons of two different exercise modalities among a total of 24 age-, sex-, and insulin-dose-matched adolescents with T1D (12 using MiniMed 780G and 12 using Tandem Control-IQ). Endpoint: The primary endpoint is sensor-derived time in range (3.9 mmol/L-10.0 mmol/L) around exercise

NCT ID: NCT05616273 Recruiting - Type 1 Diabetes Clinical Trials

Stimulated Glucagon as a Biomarker of Hypoglycemic Risk in Type 1 Diabetes

MUGGLE
Start date: March 23, 2023
Phase:
Study type: Observational

Type 1 diabetes (T1D) results from destruction of insulin producing beta cells by the body's own immune system (autoimmunity) causing an individual to lose the ability to make enough insulin to control their blood sugar levels and need to have insulin injections to lower blood glucose levels. Whilst high blood sugar level is a problem for people with Type 1 diabetes, taking insulin medication to lower sugar levels, delayed meals and exercise can all result in dangerously low blood sugar levels (hypoglycaemia). The biological causes of hypoglycaemia, and ways to prevent it are poorly understood. In non-diabetic individuals, a hormone called glucagon is secreted naturally to raise blood glucose levels but it is unclear why glucagon secretion is impaired during hypoglycaemia in individuals with T1D. The aim of this prospective observational study is to test the relationship between a glucagon stimulation test and risk of hypoglycaemia in T1D. It is hoped this research will establish whether this relationship could be used as a blood test and be a clinically useful biomarker of hypoglycaemia risk and, therefore, directly inform clinical care of people with T1D, particularly those with highest risk of hypoglycaemia. Assessment of beta cell decline has traditionally relied on timed C-peptide measures following a standardised liquid meal known as the mixed meal tolerance test (MMTT). Home finger prick blood spot C-peptide measurement might be a practical, cheap, and non-invasive alternative to a MMTT and would allow regular assessment of beta cell function over time. If proven that this sample type is a robust alternative to the gold standard MMTT venous C-peptide, it would dramatically decrease the cost and participant burden of T1D research into beta cell function.

NCT ID: NCT05610111 Recruiting - Type 1 Diabetes Clinical Trials

Adaptive Biobehavioral Control (ABC) in a Closed-Loop System

ABC-WIT
Start date: January 18, 2023
Phase: N/A
Study type: Interventional

This study is intended to test a Web-based Information Tool (WIT) software providing additional information regarding time in range, GMI, hypo- and hyperglycemia risks, variability tracker, daily glycemic profiles, and potential changes of insulin pump parameters, to users of a commercially available Closed-Loop Control (CLC) System (Control-IQ Technology).

NCT ID: NCT05594563 Recruiting - Type 1 Diabetes Clinical Trials

TArgeting Type 1 Diabetes Using POLyamines (TADPOL)

TADPOL
Start date: March 14, 2023
Phase: Phase 2
Study type: Interventional

The goal of this clinical trial is to test a drug known as DFMO in people with Type 1 Diabetes (T1D). The main question[s] it aims to answer are: - Does it reduce stress on the cells that make insulin? - Does it preserve what is left of the body's insulin production? Participants will take either DFMO or a placebo (looks like DFMO but has no active ingredients) two times a day for about 6 months. Participants will have 6 in person visits and 1 phone visit over a period of 12 months. Visits will include blood draws urine collection and other tests.

NCT ID: NCT05560568 Recruiting - Type 1 Diabetes Clinical Trials

Effects of Optimizing Nocturnal Glycemic Control on Sleep Parameters in Type 1 Diabetes

DIABNIGHT
Start date: January 20, 2023
Phase:
Study type: Observational

Sleep is crucial for physical and mental health. Environmental, social, or professional pressures can cause sleep duration to fall below the recommended 7-9 hours of sleep per night. Young adults with type 1 diabetes, have additional interference with fear, control and management of hypo/hyperglycemia management, alarms from their devices, which delay bedtime, disrupt sleep and generate multiple awakenings and difficulty returning to sleep. Sleep disturbance is correlated with blood glucose variability as recently demonstrated by a coupled analysis of sleep and glucose level collected by Continuous Glucose Monitoring (CGM). In this study, higher glucose variability predicted impaired sleep at the individual level. Automated insulin infusion has shown impressive results in clinical and real-life studies, with more than 90% of patients achieving good glycemic control. Il seems to improve sleep quality in subjects after 4 weeks in hybrid closed-loop, self-administered studies compared to a control group. The main objective of our study is to measure the positive influence of a better glycemic control on the different sleep parameters in subjects with type 1 diabetes at the time of the passage in hybrid closed-loop and in comparison to an identical period in open-loop.

NCT ID: NCT05546281 Recruiting - Type 1 Diabetes Clinical Trials

Study of the Characteristics of Orthorexia Nervosa in the Population Living With Type 1 Diabetes

Santal-DT1
Start date: October 1, 2022
Phase:
Study type: Observational

In the general population, the excessive and constant desire to control one's diet and body has become increasingly problematic. Indeed, the demand for control over one's diet and body is now an unspoken social prescription that can lead in some cases to eating disorders. In patients with type 1 diabetes (T1D), these concerns are even more central, as they are accentuated by the very nature of the treatment of the disease (dietary modification, insulin compensation according to food intake, etc.). Studies on adolescents with T1D show that the prevalence of eating disorders would be present in at least 1 in 5 patients. Among these disorders, orthorexia is of particular interest. Indeed, orthorexia was defined in 1997 by Steven Bratman as a rigid eating behavior based on the avoidance of foods considered qualitatively unhealthy. More precisely, orthorexia is characterized by a constant preoccupation with one's diet and persistent nutritional (or health) beliefs that take precedence over food pleasure. It has been estimated that the prevalence of orthorexia in patients living with T1D may be as high as 80%. We are currently conducting a study on the mechanisms of orthorexia in the general population of Quebec (the results of phase 1 of this study are being analyzed). We now wish to conduct the same study in a population with T1D, which has a higher prevalence of people with orthorexia nervosa. The main objective of this study is to investigate the characteristics of orthorexia nervosa (obsessions and fixations on healthy eating) in the Quebec population with T1D from the BETTER Registry.